Biopsy device tissue sample holder with removable tray

ABSTRACT

A biopsy device comprises a body, a needle, a cutter, and a tissue sample holder. The tissue sample holder comprises an outer cup and a cap. A tray retains severed tissue samples from a biopsy procedure. In some versions, the tray is selectively detachable from the cap in a one-handed operation by the user. The tray may be ejected into a sample container, such as a formalin cup. The cap may include a threaded portion that is configured to engage a complementary threaded portion of a sample container to seal the sample container once the tissue samples have been transferred to the sample container from the tissue sample holder of the biopsy device. One or more ports may be provided in the cap to manage excess fluid within the outer cup of the tissue sample holder, and/or to provide integrated access for a marker delivery device.

PRIORITY

This application claims priority to U.S. Provisional Application Ser.No. 61/381,466, filed Sep. 10, 2010, entitled “Biopsy Device TissueSample Holder with Removable Basket,” the disclosure of which isincorporated by reference herein.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under stereotactic guidance, ultrasound guidance, MRI guidance, PEMguidance, BSGI guidance, or otherwise. For instance, some biopsy devicesmay be fully operable by a user using a single hand, and with a singleinsertion, to capture one or more biopsy samples from a patient. Inaddition, some biopsy devices may be tethered to a vacuum module and/orcontrol module, such as for communication of fluids (e.g., pressurizedair, saline, atmospheric air, vacuum, etc.), for communication of power,and/or for communication of commands and the like. Other biopsy devicesmay be fully or at least partially operable without being tethered orotherwise connected with another device.

Merely exemplary biopsy devices are disclosed in U.S. Pat. No.5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pat. No. 6,626,849, entitled “MRICompatible Surgical Biopsy Device,” issued Sep. 30, 2003; U.S. Pub. No.2006/0074345, entitled “Biopsy Apparatus and Method,” published Apr. 6,2006; U.S. Pat. No. 7,442,171, entitled “Remote Thumbwheel for aSurgical Biopsy Device,” issued Oct. 28, 2008; U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008; U.S. Pat. No. 7,854,706, entitled “Clutch andValving System for Tetherless Biopsy Device,” issued Dec. 21, 2010; U.S.Pub. No. 2010/0152610, entitled “Hand Actuated Tetherless Biopsy Devicewith Pistol Grip,” published Jun. 17, 2010; U.S. Pub. No. 2010/0160819,entitled “Biopsy Device with Central Thumbwheel,” published Jun. 24,2010; U.S. Pub. No. 2010/0317997, entitled “Tetherless Biopsy Devicewith Reusable Portion,” published Dec. 16, 2010; U.S. patent applicationSer. No. 12/953,715, entitled “Handheld Biopsy Device with NeedleFiring,” filed Nov. 24, 2010; U.S. patent application Ser. No.13/086,567, entitled “Biopsy Device with Motorized Needle Firing,” filedApr. 14, 2011; U.S. patent application Ser. No. 13/099,497, entitled“Biopsy Device with Manifold Alignment Feature and Tissue Sensor,” filedMay 3, 2011; U.S. patent application Ser. No. 13/150,950, entitled“Needle Assembly and Blade Assembly for Biopsy Device,” filed Jun. 1,2011; and U.S. patent application Ser. No. 13/205,189, entitled “AccessChamber and Markers for Biopsy Device,” filed Aug. 8, 2011. Thedisclosure of each of the above-cited U.S. patents, U.S. patentapplication Publications, and U.S. Non-Provisional patent applicationsis incorporated by reference herein.

In some settings, it may be desirable to mark the location of a biopsysite for future reference. For instance, one or more markers may bedeposited at a biopsy site before, during, or after a tissue sample istaken from the biopsy site. Exemplary devices and methods for marking abiopsy site are disclosed in U.S. Pub. No. 2011/0071423, entitled“Flexible Biopsy Marker Delivery Device,” published Mar. 24, 2011; U.S.Pub. No. 2011/0071424, entitled “Biopsy Marker Delivery Device,”published Mar. 24, 2011; U.S. Pub. No. 2011/0071391, entitled “BiopsyMarker Delivery Device with Positioning Component,” published Mar. 24,2011; U.S. Pub. No. 2011/0071431, entitled “Biopsy Marker DeliveryDevice,” published Mar. 24, 2011; U.S. Pub. No. 2009/0209854, entitled“Biopsy Method,” published Aug. 20, 2009; U.S. Pub. No. 2009/0270725,entitled “Devices Useful in Imaging,” published Oct. 29, 2009; U.S. Pub.No. 2010/0049084, entitled “Biopsy Marker Delivery Device,” publishedFeb. 25, 2010; U.S. Pat. No. 6,228,055, entitled “Devices for Markingand Defining Particular Locations in Body Tissue,” issued May 8, 2001;U.S. Pat. No. 6,371,904, entitled “Subcutaneous Cavity Marking Deviceand Method,” issued Apr. 16, 2002; U.S. Pat. No. 6,993,375, entitled“Tissue Site Markers for In Vivo Imaging,” issued Jan. 31, 2006; U.S.Pat. No. 6,996,433, entitled “Imageable Biopsy Site Marker,” issued Feb.7, 2006; U.S. Pat. No. 7,044,957, entitled “Devices for Defining andMarking Tissue,” issued May 16, 2006; U.S. Pat. No. 7,047,063, entitled“Tissue Site Markers for In Vivo Imaging,” issued May 16, 2006; U.S.Pat. No. 7,229,417, entitled “Methods for Marking a Biopsy Site,” issuedJun. 12, 2007; U.S. Pat. No. 7,465,279, entitled “Marker Device andMethod of Deploying a Cavity Marker Using a Surgical Biopsy Device,”issued Dec. 16, 2008; and U.S. patent application Ser. No. 13/205,189,entitled “Access Chamber and Markers for Biopsy Device,” filed Aug. 8,2011. The disclosure of each of the above-cited U.S. patents, U.S.patent application Publications, and U.S. patent applications isincorporated by reference herein.

While several systems and methods have been made and used for obtaininga biopsy sample and marking the sample location, it is believed that noone prior to the inventors has made or used the invention described inthe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements.

FIG. 1 depicts a perspective view of an exemplary biopsy device;

FIG. 2 depicts a block schematic view of components that are part of, orused with, the device of FIG. 1;

FIG. 3 depicts a first series view of part of the needle of the biopsydevice of FIG. 1, with the needle shown in cross section and with thecutter in the initial, distal position;

FIG. 4 depicts a second series view of part of the needle of the biopsydevice of FIG. 1, with the needle shown in cross section and with thecutter in an intermediate position during retraction;

FIG. 5 depicts a third series view of part of the needle of the biopsydevice of FIG. 1, with the needle shown in cross section and with thecutter in the retracted, proximal position;

FIG. 6 depicts a fourth series view of part of the needle of the biopsydevice of FIG. 1, with the needle shown in cross section and with thecutter in the advanced, distal position;

FIG. 7 depicts a perspective view of an exemplary marker deliverydevice;

FIG. 8 depicts a cross-sectional view of a distal portion of the markerdelivery device of FIG. 7;

FIG. 9 depicts a side view the marker delivery device of FIG. 7 insertedin a biopsy device needle, with the biopsy device needle shown incross-section, and with a marker being deployed through aligned lateralopenings of the marker delivery device and the biopsy device needle;

FIG. 10 depicts a side view of an exemplary tray and cap of a tissuesample holder;

FIG. 11 depicts a front view of the tray and cap of FIG. 10, shown fromthe tray end;

FIG. 12 depicts a top view of the tray and cap of FIG. 10, shown withthe tray and cap removed from an outer cup, but with tray attached tocap;

FIG. 13 depicts a top view of the tray and cap of FIG. 10, shown withthe tray ejected from the cap;

FIG. 14 depicts a perspective view of an exemplary outer cup of a tissuesample holder;

FIG. 15 depicts a perspective view of an exemplary cap of a tissuesample holder;

FIG. 16 depicts a perspective view of an exemplary sample container;

FIG. 17 depicts an exemplary cap for a tissue sample holder, with thecap having a port for fluid management;

FIG. 18 depicts a cross-sectional view of the cap of FIG. 17;

FIG. 19 depicts a perspective view of an exemplary tray and cap of atissue sample holder;

FIG. 20 depicts another perspective view of the tray and cap of FIG. 19;

FIG. 21 depicts a cross-sectional view of the tray and cap of FIG. 19;

FIG. 22 depicts a front view of the tray and cap of FIG. 19, shown fromthe tray end;

FIG. 23 depicts a perspective view of another exemplary biopsy device;

FIG. 24 depicts a block schematic view of various components of thedevice of FIG. 23;

FIG. 25 depicts a perspective view of a holster recharging station foruse with the device of FIG. 23;

FIG. 26 depicts a rear perspective view of an exemplary alternativetissue sample holder with a portion cut away to reveal a removable trayand other features;

FIG. 27 depicts a cross-sectional view of the alternative tissue sampleholder of FIG. 26;

FIG. 28 depicts an exploded perspective view of the tissue sample holderof FIG. 26;

FIG. 29 depicts a cross-sectional view of the tissue sample holder ofFIG. 26, with a plug adapter in place of the removable tray;

FIG. 30 depicts an exploded perspective view of the tissue sample holderand plug adapter of FIG. 29;

FIG. 31 depicts a cross-sectional view of still another exemplary tissuesample holder, with a removable tray; and

FIG. 32 depicts an exploded perspective view of the tissue sample holderof FIG. 31.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

I. Overview

A. Exemplary Biopsy Device

As shown in FIG. 1, an exemplary biopsy device (10) comprises a needle(20), a body (30), a tissue sample holder (40), and a cutter (50). Inparticular, needle (20) extends distally from the distal portion of body(30), while tissue sample holder (40) extends proximally from theproximal portion of body (30). Body (30) is sized and configured suchthat biopsy device (10) may be operated by a single hand of a user. Inparticular, a user may grasp body (30), insert needle (20) into apatient's breast, and collect one or a plurality of tissue samples fromwithin the patient's breast, all with just using a single hand.Alternatively, a user may grasp body (30) with more than one hand and/orwith any desired assistance. In some settings, the user may capture aplurality of tissue samples with just a single insertion of needle (20)into the patient's breast. Such tissue samples may be pneumaticallydeposited in tissue sample holder (40), and later retrieved from tissuesample holder (40) for analysis. While examples described herein oftenrefer to the acquisition of biopsy samples from a patient's breast, itshould be understood that biopsy device (10) may be used in a variety ofother procedures for a variety of other purposes and in a variety ofother parts of a patient's anatomy.

Needle (20) of the present example comprises a cannula (21) with atissue piercing tip (22), a lateral aperture (23), and a hub (24).Tissue piercing tip (22) is configured to pierce and penetrate tissue,without requiring a high amount of force, and without requiring anopening to be pre-formed in the tissue prior to insertion of tip (22).Alternatively, tip (22) may be blunt (e.g., rounded, flat, etc.) ifdesired. Lateral aperture (23) is sized to receive a tissue from atissue specimen during operation of device (10). Within cannula (21)resides cutter (50), which rotates and translates relative to cannula(21) and past lateral aperture (23) to sever a tissue sample from tissueprotruding through lateral aperture (23). Hub (24) may be formed ofplastic that is overmolded about needle (20) or otherwise secured toneedle (20), such that hub (24) is unitarily secured to needle (20).Alternatively, hub (24) may be formed of any other suitable materialthrough any suitable process and may have any other suitablerelationship with needle (20). Hub (24) of the present example iscoupled with a vacuum conduit (not shown), and is operable tocommunicate a vacuum (or atmospheric air, saline, pressurized fluid,etc.) from vacuum conduit to lateral aperture (23). The vacuum conduitmay be coupled with a variety of sources, including but not limited to avacuum source that is internal or external to biopsy device (10) inaccordance with the teachings of U.S. Pub. No. 2010/0317997, entitled“Tetherless Biopsy Device with Reusable Portion,” published Dec. 16,2010, and/or U.S. Pub. No. 2008/0214955, entitled “Presentation ofBiopsy Sample by Biopsy Device,” published Sep. 4, 2008, the disclosuresof which are incorporated by reference herein. Still other suitablefluid sources that a vacuum conduit may be coupled with will be apparentto those of ordinary skill in the art in view of the teachings herein.Of course, any suitable type of valve(s) and/or switching mechanism(s)may also be coupled with vacuum conduit, e.g., as taught in U.S. Pub.No. 2010/0317997, entitled “Tetherless Biopsy Device with ReusablePortion,” published Dec. 16, 2010, and/or U.S. Pub. No. 2008/0214955,entitled “Presentation of Biopsy Sample by Biopsy Device,” publishedSep. 4, 2008, the disclosures of which are incorporated by referenceherein. It should also be understood that a vacuum, atmospheric air, aliquid such as saline, etc. may also be selectively communicated to thelumen defined by cutter (50).

Body (30) of the present example comprises a housing (31). In someversions, body (30) is formed in at least two pieces, comprising a probeportion and a holster portion. For instance, in some such versions, theprobe portion may be separable from the holster portion. Furthermore,the probe portion may be provided as a disposable component while theholster portion may be provided as a reusable portion. By way of exampleonly, such a probe and holster configuration may be provided inaccordance with the teachings of U.S. Pub. No. 2010/0317997, entitled“Tetherless Biopsy Device with Reusable Portion,” published Dec. 16,2010, and/or U.S. Pub. No. 2008/0214955, entitled “Presentation ofBiopsy Sample by Biopsy Device,” published Sep. 4, 2008, and/or U.S.patent application Ser. No. 12/953,715, entitled “Handheld Biopsy Devicewith Needle Firing,” filed Nov. 24, 2010, the disclosures of which areincorporated by reference herein. Alternatively, any other suitableprobe and holster configuration may be used. It should also beunderstood that body (30) may be configured such that it does not have aseparable probe portion and holster portion. Various other suitable waysin which body (30) may be configured will be apparent to those ofordinary skill in the art in view of the teachings herein.

Tissue sample holder (40) of the present example comprises a cap (41)and an outer cup (42). As will be described in greater detail below, atray (46) (shown in FIGS. 10-13) is provided within outer cup (42). Cup(42) is secured to body (30) in the present example. Such engagement maybe provided in any suitable fashion. Outer cup (42) of the presentexample is substantially transparent, allowing the user to view tissuesamples on tray (46), though outer cup (42) may have any other suitableproperties if desired.

The hollow interior of outer cup (42) is in fluid communication withcutter (50) and with a vacuum source (70) in the present example. Thus,when a tissue sample has been severed from a tissue specimen by cutter(50), the tissue sample is pulled from cutter (50) to tissue sampleholder (40) by vacuum. In the present example, and as will be describedin greater detail below, vacuum source (70) may be within body (30) orexternal to body (30). By way of example only, vacuum may be provided toouter cup (42), and such a vacuum may be further communicated to cutter(50), in accordance with the teachings of U.S. Pub. No. 2010/0317997,entitled “Tetherless Biopsy Device with Reusable Portion,” publishedDec. 16, 2010, and/or U.S. patent application Ser. No. 12/953,715,entitled “Handheld Biopsy Device with Needle Firing,” filed Nov. 24,2010, the disclosures of which are incorporated by reference herein. Asanother merely illustrative example, vacuum may be provided to outer cup(42) from an external vacuum source (70) in accordance with theteachings of U.S. Pub. No. 2008/0214955, entitled “Presentation ofBiopsy Sample by Biopsy Device,” published Sep. 4, 2008, the disclosureof which is incorporated by reference herein. Various other suitableways in which vacuum may be provided to outer cup (42) will be apparentto those of ordinary skill in the art in view of the teachings herein.It should also be understood that outer cup (42) may receive vacuum fromthe same vacuum source (70) as the vacuum conduit in needle (20). Biopsydevice (10) may further include one or more valves (e.g., shuttle valve,electromechanical solenoid valve, etc.) to selectively regulatecommunication of a vacuum and/or other fluids to outer cup (42) and/orvacuum conduit, regardless of whether outer cup (42) and vacuum conduitare coupled with a common source of vacuum or other source of fluid.

Cap (41) is removably coupled with outer cup (42) in the present examplesuch that a user may remove cap (41) to access tissue samples that havebeen gathered on the tray (46) within outer cup (42) during a biopsyprocess. A pair of latches (43) provide selective engagement between cap(41) and outer cup (42). In particular, latches (43) engage a lip (44)of outer cup (42). Lip (44) has gaps (45) permitting passage of latches(43), such that a user may secure cap (41) to outer cup (42) by aligninglatches (43) with gaps (45), pushing cap (41) onto outer cup (42), thenrotating cap (41) past gaps (45) to engage latches (43) with lip (44).Alternatively, cap (41) may be secured to outer cup (42) in any othersuitable fashion (e.g., latches (43) having resilient properties and/orliving hinges to permit engagement of latches (43) with lip (44), etc.).An o-ring (not shown) provides a seal when cap (41) is engaged withouter cup (42). A vacuum may thus be maintained within outer cup (42)when cap (41) is secured to outer cup (42). In operation, a user mayremove cap (41) to access tissue samples that have gathered on a tray(46) within outer cup (42) during a biopsy process. In the presentexample, cap (41) is removed by rotating cap (41) to align latches (43)with gaps (45), then pulling cap (41) off. Of course, cap (41) may beremoved from outer cup (42) in any other suitable fashion.

Tissue sample holder (40) of the present example is configured to holdat least ten tissue samples. Alternatively, tissue sample holder (40)may be configured to hold any other suitable number of tissue samples.It should be understood that, as with other components described herein,tissue sample holder (40) may be varied, modified, substituted, orsupplemented in a variety of ways; and that tissue sample holder (40)may have a variety of alternative features, components, configurations,and functionalities. For instance, tissue sample holder (40) may bealternatively configured such that, in lieu of having a stationary tray(46), tissue sample holder (40) may have a plurality of trays orcompartments that are removably coupled with a rotatable manifold, suchthat the manifold is operable to successively index each tray orcompartment relative to cutter (50) to separately receive tissue samplesobtained in successive cutting strokes of cutter (50). For instance,tissue sample holder (40) may be constructed and operable in accordancewith the teachings of U.S. Pub. No. 2008/0214955, entitled “Presentationof Biopsy Sample by Biopsy Device,” published Sep. 4, 2008, thedisclosure of which is incorporated by reference herein. Such indexingmay be provided automatically or manually. By way of example only,tissue sample holder (40) may be configured and operable in accordancewith the teachings of U.S. Pub. No. 2008/0195066, entitled “RevolvingTissue Sample Holder for Biopsy Device,” published Aug. 14, 2008, thedisclosure of which is incorporated by reference herein; U.S. Pub. No.2010/0160826, entitled “Tissue Biopsy Device with Rotatably LinkedThumbwheel and Tissue Sample Holder,” published Jun. 24, 2010; U.S. Pub.No. 2010/0160824, entitled “Biopsy Device with Discrete TissueChambers,” published Jun. 24, 2010, the disclosure of which isincorporated by reference herein; or U.S. Pub. No. 2010/0160816,entitled “Mechanical Tissue Sample Holder Indexing Device,” publishedJun. 24, 2010, the disclosure of which is incorporated by referenceherein. In some other versions, tissue sample holder (40) is configuredin accordance with the teachings of U.S. Pub. No. 2010/0317997, entitled“Tetherless Biopsy Device with Reusable Portion,” published Dec. 16,2010, the disclosure of which is incorporated by reference herein. Othersuitable alternative versions, features, components, configurations, andfunctionalities of tissue sample holder (40) will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

It should be understood that, as with other components described herein,needle (20), body (30), tissue sample holder (40), and cutter (50) maybe varied, modified, substituted, or supplemented in a variety of ways,and that needle (20), body (30), tissue sample holder (40), and cutter(50) may have a variety of alternative features, components,configurations, and functionalities. Several merely exemplaryvariations, modifications, substitutions, or supplementations aredescribed in U.S. Non-Provisional patent application Ser. No.12/709,624, entitled “Spring Loaded Biopsy Device,” filed Feb. 22, 2010,the disclosure of which is hereby incorporated by reference. Still yet,other suitable alternative versions, features, components,configurations, and functionalities of needle (20), body (30), tissuesample holder (40), and cutter (50) will be apparent to those ofordinary skill in the art in view of the teachings herein.

As shown in FIG. 2, exemplary components that are part of, or used with,the device of FIG. 1, some of which have been introduced above, includea power source (60), a vacuum source (70), a vacuum control module (80),a motor (90), a set of gears (100), and a cutter actuator (110). In thepresent example, power source (60) provides power to vacuum source (70),vacuum control module (80), and motor (90). In some versions, powersource (60) is located onboard biopsy device (10), e.g., a battery;while in some other versions, power source (60) is located some distancefrom biopsy device (10), e.g., line voltage from a standard electricalreceptacle with a cable connection to biopsy device (10) and/or throughan additional module between an electrical receptacle and biopsy device(10). Various configurations for and modifications to power source (60)will be apparent to those of ordinary skill in the art in view of theteachings herein.

In the present example, vacuum source (70) provides vacuum to biopsydevice (10) for drawing tissue into lateral aperture (23) of needle(20). Vacuum source (70) also provides vacuum to biopsy device (10) fortransporting a severed tissue sample from cutter (50) to tissue sampleholder (40). In some versions, vacuum source (70) comprises a vacuumpump located onboard biopsy device (10). By way of example only, such anonboard vacuum source (70) may comprise a diaphragm pump that is drivenby motor (90). In some such versions, vacuum source (70) is not coupledwith power source (60) and vacuum control module (80) is omitted. Insome other versions, vacuum source (70) comprises a vacuum pump locatedsome distance from biopsy device (10) that provides vacuum via a vacuumcable or conduit. Of course, vacuum source (70) may comprise acombination of a vacuum pump located within housing (31) and a vacuumpump that is external to housing (31), if desired. In the presentexample, vacuum source (70) is in communication with vacuum controlmodule (80). Vacuum control module (80) includes functions to controlthe supply and delivery of vacuum from vacuum source (70) to biopsydevice (10). Various functions and capabilities that can be used withvacuum control module (80) to control how vacuum is supplied anddelivered will be apparent to those of ordinary skill in the art in viewof the teachings herein. Also, various other configurations for, andmodifications to, vacuum source (70) and vacuum control module (80) willbe apparent to those of ordinary skill in the art based on the teachingsherein.

Motor (90) of the present example comprises a conventional DC motor,though it should be understood that any other suitable type of motor maybe used. By way of example only, motor (90) may comprise a pneumaticmotor (e.g., having an impeller, etc.) that is powered by pressurizedair, a pneumatic linear actuator, an electromechanical linear actuator,a piezoelectric motor (e.g., for use in MRI settings), or a variety ofother types of movement-inducing devices. As mentioned above, motor (90)receives power from power source (60). In some versions, motor (90) islocated onboard biopsy device (10) (e.g., within housing (31)). In someother versions, motor (90) is located some distance from biopsy device(10) and provides energy to biopsy device (10) via a drive shaft orcable. In the present example, motor (90) is operable to rotate a driveshaft (not shown), which extends distally from motor (90) to gear set(100) to provide a rotary input into gear set (100). While the driveshaft extends directly from motor (90) into gear set (100), it should beunderstood that a variety of other components may be coupled betweenmotor (90) and gear set (100), including but not limited to variousgears, a clutch, etc. Gear set (100) includes an output shaft (notshown) having a drive gear (not shown) secured thereto, and is operableto selectively activate cutter actuator (110). Gear set (100) maycomprise a planetary gearbox, and may be configured to provide speedreduction. Various suitable configurations for motor (90) and gear set(100) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

Cutter actuator (110) of the present example comprises a variety ofcomponents that interact to provide simultaneous rotation and distaltranslation of cutter (50) relative to body (30) and needle (20) in afiring stroke. Cutter actuator (110) is also operable to retract cutter(50) proximally to ready cutter (50) for firing. By way of example only,cutter actuator (110) may be configured and operable in accordance withthe teachings of U.S. Non-Provisional patent application Ser. No.12/709,624, entitled “Spring Loaded Biopsy Device,” filed Feb. 22, 2010,and/or U.S. Pub. No. 2008/0214955, entitled “Presentation of BiopsySample by Biopsy Device,” published Sep. 4, 2008, the disclosures ofwhich are incorporated by reference herein. It should be understoodthat, as with other components described herein, cutter actuator (110)may be varied, modified, substituted, or supplemented in a variety ofways, and that cutter actuator (110) may have a variety of alternativefeatures, components, configurations, and functionalities. Suitablealternative versions, features, components, configurations, andfunctionalities of cutter actuator (110) will be apparent to those ofordinary skill in the art in view of the teachings herein.

As shown in the series views of FIGS. 3-6, an exemplary cutter (50)firing sequence is shown. FIG. 3 depicts cutter (50) in a distalposition, with distal edge (51) of cutter (50) positioned distal oflateral aperture (23) thereby effectively “closing” lateral aperture(23) of needle (20). In this configuration, needle (20) can be insertedwithout tissue prolapsing through lateral aperture (23). FIG. 4 depictscutter (50) being retracted by cutter actuator (110), thereby exposingtissue to lateral aperture (23) and revealing a cutter lumen (52) ofcutter (50). In the present example, cutter (50) is positioned within afirst lumen (25) of cannula (21). Beneath first lumen (25) is a secondlumen (26), which is in part defined by a divider (27). Divider (27)comprises a plurality of openings (28) that provide fluid communicationbetween first and second lumens (25, 26). A plurality of externalopenings (not shown) may also be formed in needle (20), and may be influid communication with second lumen (26). For instance, such externalopenings may be configured in accordance with the teachings of U.S. Pat.No. 7,918,804, entitled “Biopsy Device with Vacuum Assisted BleedingControl,” issued Apr. 5, 2011, the disclosure of which is incorporatedby reference herein. Cutter (50) may also include one or more sideopenings (not shown). Of course, as with other components describedherein, such external openings in needle (20) and cutter (50) are merelyoptional.

FIG. 5 depicts cutter (50) fully retracted by cutter actuator (110),such that lateral aperture (23) is completely unobstructed by cutter(50). In this configuration tissue can prolapse through lateral aperture(23) within first lumen (25) under the force of gravity, due to internalpressure of the tissue (e.g., caused by displacement of the tissue uponinsertion of needle (20), etc.), and/or with vacuum provided throughsecond lumen (26) and transmitted through openings (28) and/or by vacuumprovided through cutter lumen (52). FIG. 6 depicts cutter (50) after ithas been advanced to close off lateral aperture (23) once tissue hasbeen captured within first lumen (25) (shown best in FIG. 5). With thetissue severed, it is captured within cutter lumen (52) and ready forproximal transport to tissue sample holder (40). Such proximal transportof tissue through cutter lumen (52) to reach tissue sample holder (40)may be provided by drawing a vacuum through the proximal portion ofcutter lumen (52) (e.g., behind the captured tissue sample) whileventing a distal portion of cutter lumen (52) (e.g., in front of thecaptured tissue sample) to provide a pressure differential.Alternatively, tissue samples severed by cutter (50) may be communicatedproximally to tissue sample holder (40) or be otherwise dealt with inany other suitable fashion.

B. Exemplary Marker Delivery Device

After obtaining a tissue sample, in some settings, it may be desirableto mark the location of the biopsy site for future reference. Forinstance, one or more markers may be deposited at a biopsy site after atissue sample is taken from the biopsy site. Of course one or moremarkers may be deposited at a biopsy site before or during the sampletaking procedure as well. FIGS. 7-9 illustrate an exemplary markerdelivery device (1000), which includes an elongate flexible outerdeployer tube (1002) a side opening (1004) formed near to, but spacedproximally from, the distal end of the deployer tube (1002). A grip(1006) is provided at the proximal end of deployer tube (1002). A pushrod (1008) extends coaxially in deployer tube (1002) such that push rod(1008) is configured to translate within deployer tube (1002) todisplace one or more markers (1100) through the side opening (1004) asshown in FIG. 9. Deployer tube (1002) and rod (1008) may be relativelyflexible in bending so that the deployer tube (1002) may be insertedalong a straight or curved path to deploy a marker (1100) at a biopsysite. A plunger (1010) is provided at the proximal end of rod (1008) forpushing rod (1008) distally in deployer tube (1002) to deploy a marker(1100) out of the deployer tube (1002). A user may grasp grip (1006)with two fingers, and may push on plunger (1010) using the thumb on thesame hand, so that marker delivery device (1000) may be operated by auser's single hand. A spring (not shown) or other feature may beprovided about rod (1008) to bias rod (1008) proximally relative to grip(1006) and deployer tube (1002).

FIG. 8 depicts a cross-sectional view of a distal portion of markerdelivery device (1000). FIG. 8 shows a biopsy marker (1100) disposed inthe internal lumen (1005) of deployer tube (1002). Marker (1100) of thepresent example comprises a biodegradable or otherwise bioresorbablebody (1106), such as a generally cylindrically shaped body of collagenor other suitable polymeric material, and a metallic, generallyradiopaque marker element (1110) (shown in phantom) disposed within orotherwise carried by the body (1106). Marker (1100) may be composedand/or configured in accordance with the teachings of any of the variousU.S. patents, U.S. patent application Publications, or U.S. patentapplications cited herein. Alternatively, marker (1100) may have anyother suitable composition and/or configuration. It should also beunderstood that a plurality of markers (1100) may be provided withindeployer tube (1002) (e.g., in an end-to-end arrangement, etc.), ifdesired. If a plurality of markers (1100) are used, it should beunderstood that a plurality of markers (1100) within a single deployertube (1002) may have the same size, shape, and/or composition.Alternatively, a plurality of markers (1100) within a single deployertube (1002) may have different sizes, shapes, and/or compositions.

Deployer tube (1002) may be formed of any suitable metallic ornon-metallic material, or even a combination of metallic andnon-metallic materials. In the present example, deployer tube (1002) isformed of a relatively flexible, thin walled hollow tube formed of asuitable medical grade plastic or polymer. One suitable material is athermoplastic elastomer, such as Polyether block amide (PEBA), such asis known under the tradename PEBAX. Deployer tube (1002) may thus beformed of PEBAX, and may be substantially transparent to visible lightand X-ray. Side opening (1004) may be formed by cutting away a portionof the wall of deployer tube (1002); or using any other suitabletechnique. Side opening (1004) communicates with an internal lumen(1005) of deployer tube (1002). Side opening (1004) extends axially (ina direction parallel to the axis of lumen (1005)) from a proximalopening end (1004A) to a distal opening end (1004B), as illustrated inFIG. 8.

The distal tip (1012) extending from the distal end of deployer tube(1002) may be rounded as shown in FIG. 8. Of course, distal tip (1012)may alternatively have any other suitable configuration. Still referringto FIG. 8, marker delivery device (1000) of the present example has thedistal end of deployer tube (1002) closed by a unitary endpiece (1011)formed in place in the distal end of deployer tube (1002), with a partof endpiece (1011) extending into internal lumen (1005) of deployer tube(1002). Distal endpiece (1011) may be a molded or cast component, andmay provide an integrally formed combination of tip (1012), a ramp(1014) having a ramp surface (1016), and a marker engaging element(1018). Ramp surface (1016) may aid in directing marker (1100) frominternal lumen (1005) through side opening (1004). Marker engagingelement (1018) may be employed to substantially retain marker (1100) ininternal lumen (1005) until the user intends to deploy marker (1100).

Marker engaging element (1018) of the present example is disposed withininternal lumen (1005), and at least a portion of marker engaging element(1018) is disposed distally of proximal end (1004A) of side opening(1004). Marker engaging element (1018) extends along a portion of thefloor of lumen (1005) under the opening (1004); and is positioned toreinforce the portion of deployer tube (1002) in which opening (1004) isformed. For instance, by positioning marker engaging element (1018)underneath opening (1004) as shown in FIG. 8, marker engaging element(1018) may help to substantially stiffen deployer tube (1002) in theregion where the wall of deployer tube (1002) is cut to form opening(1004). Marker engaging element (1018) extends from the proximal-mostportion of ramp surface (1016), and does not extend proximally of sideopening (1004), though in some other versions, a portion of markerengaging element (1018) could extend proximally of opening (1004) ifdesired. Marker engaging element (1018) is in the form of a step havinga generally uniform thickness (T) along the element's axial length,except that marker engaging element (1018) has a tapered proximal end(1020) in the present example. Tapered proximal end (1020) may form anincluded angle with the longitudinal axis of the lumen (1005) (includedangle with a horizontal line in FIG. 8) of about 45 degrees, while rampsurface (1016) may form an included angle with the longitudinal axis ofabout 30 degrees. Of course, these angles are mere examples, and itshould be understood that any other suitable angles may be used. Asshown in FIG. 8, an upwardly facing surface (1022) (surface facingopening (1004)) of marker engaging element (1018) extends distally fromtapered proximal end (1020) of marker engaging element (1018) to contactramp surface (1016).

The thickness (T) of marker engaging element (1018) may be greater thanthe wall thickness (t) of deployer tube (1002). For instance, in someversions, thickness (T) is at least about twice the thickness (t). Byway of example only, the thickness (T) of marker engaging element (1018)may be between about 0.018 inch to about 0.040 inch; and the wallthickness (t) of deployer tube (1002) may be between about 0.005 inch toabout 0.008 inch. The internal diameter of lumen (1005) may be about0.120 inch. Of course, any other suitable dimensions may be used forthese components. It should be understood that, as with other componentsdescribed herein, marker engaging element (1018) may have any othersuitable configuration, and may even be omitted as desired.

If desired, the marker engaging element (1018), ramp (1014), and/or tip(1012) may be formed of, or include, a material that is relatively moreradiopaque than the wall of deployer tube (1002). For instance, wheremarker engaging element (1018), ramp (1014), and tip (1012) are formedas an integral endpiece (1011), endpiece (1011) may include a radiopaqueadditive, such as barium sulfate. By way of example only, endpiece(1011) may be a component molded of PEBAX, with about 20 percent byweight barium sulfate added to the molten PEBAX mold composition. Therelatively more radiopaque marker engaging element (1018), ramp (1014),and tip (1012) may be useful in distinguishing the position of thosecomponents using radiographic imaging. Also, where ramp (1014) and/orstep of marker engaging element (1018) is/are positioned in associationwith opening (1004), the addition of a radiopaque material may helpidentify the position of opening (1004), and the position of the marker(1100) relative to opening (1004), before, during, or after deploymentof marker (1100).

In some versions, deployer tube (1002) is generally transparent tovisible light and x-ray; while endpiece (1011) is generally opaque tovisible light and x-ray. If desired, endpiece (1011) may be colored witha dye or other suitable colorant in a liquid mold composition. Forexample, it may be desirable to have different size markers (e.g. lengthand/or diameter, etc.) for different biopsy procedures. For instance, itmay be desirable to provide a larger marker if a relatively large biopsysample is taken; and a smaller marker if a relatively small biopsysample is taken. Endpiece (1011) may be colored using one of multiplecolors to indicate the size of the marker disposed in deployer tube(1002). For instance, if three marker sizes are provided, endpiece(1011) may be colored one of three colors to identify which of themarker sizes are disposed in the particular marker delivery device(1000). Endpiece (1011) may also be colored to indicate a particularsize (e.g., diameter or length, etc.) or type of biopsy needle withwhich the marker delivery device (1000) is to be used. Additionally,multiple marker delivery devices (1000) may be packaged in kit form,with the kit including marker delivery devices (1000) having differentsize markers and correspondingly colored endpieces (1011). Still othervariations will be apparent to those of ordinary skill in the art inview of the teachings herein.

As shown in FIG. 9, marker delivery device (1000) may be used to deploya marker (1100) to mark a particular location within a patient. Forinstance, FIG. 9 depicts marker delivery device (1000) being usedthrough a biopsy needle (20). In particular, FIG. 9 shows the distal endof marker delivery device (1000) disposed within the interior of needle(20). Needle (20) of this example has a closed distal end with apiercing tip (22); and a lateral tissue receiving aperture (23). Itshould be understood that needle (20) may be positioned in tissue, and abiopsy sample may be obtained through lateral aperture (23), therebyproviding a biopsy cavity adjacent lateral aperture (23). Then, afterthe tissue sample has been obtained and transferred proximally throughneedle (20), and without removing needle (20) from the patient's tissue,marker delivery device (1000) may be inserted through a proximal opening(not shown) in needle (20) described later herein. In particular, needle(20) and marker delivery device (1000) are positioned such that opening(1004) of deployer tube (1002) and lateral aperture (23) of needle (20)are substantially aligned axially and circumferentially. Then, withmarker delivery device (1000) and needle (20) so positioned at thebiopsy cavity, push rod (1008) may be advanced to deploy marker (1100)up ramp surface (1016), through opening (1004), and then through lateralaperture (23), into the biopsy cavity.

Marker delivery device (1000) may thus be introduced to a biopsy sitethrough biopsy needle (20), which can be the same needle (20) used tocollect a tissue sample from the biopsy site. Biopsy needle (20) may beof the type used with single insertion, multiple sample vacuum assistedbiopsy devices. Several such biopsy devices are disclosed in the variousU.S. patents, U.S. patent application Publications, and U.S. patentapplications that have been referred to and incorporated by referenceherein, though it should be understood that marker delivery device(1000) may be used with various other biopsy devices.

It may be desirable in some (but not necessarily all) settings tosubstantially prevent a marker from unintentionally falling out of adeployer, such as at a time prior to the intended deployment. Inaddition, it may be desirable in some (but not necessarily all) settingsto guide and/or steady the tip of a flexible tube of a deployer as thetip is inserted into a biopsy device or other access device used toprovide a path to a biopsy site. Some of these and other modificationsand alternative configurations of a marker delivery device are describedin U.S. Pub. No. 2011/0071423, entitled “Flexible Biopsy Marker DeliveryDevice,” published Mar. 24, 2011, the disclosure of which isincorporated by reference herein; and U.S. Non-Provisional patentapplication Ser. No. 12/787,492, entitled “Biopsy Marker DeliveryDevice,” filed May 26, 2010, the disclosure of which is incorporated byreference herein.

While the above paragraphs provide an enabling description of anexemplary biopsy device (10) and marker delivery device (1000) and theiruse, further description as well as exemplary methods of operation foran exemplary biopsy device (10) are provided with the teachings of U.S.Non-Provisional patent application Ser. No. 12/709,624, entitled “SpringLoaded Biopsy Device,” filed Feb. 22, 2010, and U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008, the disclosures of which are incorporated byreference herein. Further descriptions as well as exemplary methods ofoperation for an exemplary marker delivery device (1000) are providedwith the teachings of U.S. Pub. No. 2011/0071423, entitled “FlexibleBiopsy Marker Delivery Device,” published Mar. 24, 2011, the disclosureof which is incorporated by reference herein; U.S. Non-Provisionalpatent application Ser. No. 12/787,492, entitled “Biopsy Marker DeliveryDevice,” filed May 26, 2010, the disclosure of which is incorporated byreference herein; and U.S. patent application Ser. No. 13/205,189,entitled “Access Chamber and Markers for Biopsy Device,” filed Aug. 8,2011, the disclosure of which is incorporated by reference herein. Ofcourse, the above examples of construction and use of biopsy device (10)and marker delivery device (1000) are merely illustrative. Othersuitable ways in which biopsy device (10) and marker delivery device(1000) may be made and used will be apparent to those of ordinary skillin the art in view of the teachings herein.

II. Exemplary Tissue Sample Holder with Removable Tray

FIGS. 10-13 show an exemplary tissue sample cap (41) and tray (46).Tissue sample cap (41) and tray (46) of the present example arecomponents of tissue sample holder (40) described above. For instance,cap (41) shown in FIGS. 10-13 is operable with cup (42) as shown in FIG.1 and described above. As discussed, latches (43) of cap (41) cooperatewith features of cup (42) to removably secure cap (41) to cup (42). Asdiscussed below in greater detail, latches (43) of cap (41) cooperatewith features of tray (46) to disengage tray (46) from cap (41).

As shown in FIG. 10, tray (46) is integral with cap (41). Thus, when cap(41) is removed from cup (42), both cap (41) and attached tray (46) areremoved from cup (42) as a single unit. In some versions, tray (46) isremovably secured to cap (41), such that tray (46) may be separated fromcap (41). In the present example, tray (46) is removably secured to cap(41) by an interference fitting or snap fitting. For example, tray (46)includes proximal end (47), which has a generally rectangular shape inthe present example, although other shapes could be used as well.Proximal end (47) is configured such that it engages with an interiorreceiving member (48) of cap (41). Interior receiving member (48) isconfigured such that it includes a docking member (not shown) to whichproximal end (47) fits snugly against so as to create an interferencefitting between the two. In some versions, an o-ring (not shown) orelastomeric material may be included on the docking member (not shown)and/or proximal end (47) for creating a frictionally secure and sealedconnection between tray (46) and cap (41). While the above describedinterference fitting is one way to securely, yet removably, attachedtray (46) to cap (41), other suitable ways in which to connect tray (46)to cap (41) will be apparent to those of ordinary skill in the art basedon the teachings herein.

Tray (46) of the present example comprises sample surface (402) andopenings (404). As shown in FIGS. 12-13, sample surface (402) isconfigured to receive tissue samples (410) that were severed by cutterin a biopsy procedure. In the present example, tissue samples (410) aretransported through the cutter lumen (52) to sample surface (402) byvacuum. Of course other means to deposit tissue samples (410) on samplesurface (402) (e.g., pressurized fluid such as air or saline, etc.) willbe apparent to those of ordinary skill in the art based on the teachingsherein. Also as shown in FIGS. 10-13, sample surface (402) comprisesupright side portions (406) and inclined faces (408). Inclined faces(408) couple sample surface (402) and upright side portion (406) withproximal end (47) of tray (46). Openings (404) of tray (46) arepositioned along upright side portions (406) of tray (46) and alongsample surface (402). Of course, openings (404) may alternatively haveany other suitable arrangement that will be apparent to those ofordinary skill in the art based on the teachings herein; or openings(404) may be eliminated entirely. In the present example, openings (404)are large enough to permit fluid that is transported to tray (46) (e.g.,by vacuum along with the tissue samples, or by vacuum as part of adrainage procedure, etc.) to flow through tray (46) and be collected byanother structure (e.g., in the present example the fluid passingthrough openings (404) is retained within cup (42); yet are small enoughsuch that tissue samples (410) are retained on sample surface (402)).

Tray (46) of the present example is constructed from a transparentplastic. Of course other materials, including non-transparent materials,may be used in other versions as will be appreciated by those ofordinary skill in the art based on the teachings herein. In someversions, tray (46) includes a ceiling member (not shown) that connectsto upright side portions (406) and thus extends above and over samplesurface (402). In some such versions, all of tray (46) or portions oftray (46) are constructed from a transparent plastic. Having a tray (46)with all or a portion constructed from transparent materials may permita user to visualize the collected tissue samples (410) once cap (41) andtray (46) have been removed from cup (42). Of course, in some otherversions, all or portions of cup (42) may also be made from transparentmaterials such that collected tissue samples (410) can be visualizedeven when cap (41) is still connected with cup (42), tray (46) beinglocated within cup (42).

As shown by comparing FIGS. 12 and 13, another feature of the presentcap (41) and tray (46) combination is the ability to eject tray (46)from cap (41). With an ejectable tray (46), the entire tray (46)including any tissue samples (410) captured on sample surface (402) canmay be ejected from cap (41) into a container of formalin or some otherfluid. In the present example, latches (43) have resilient properties.When latches (43) are pushed from outer sides (412) toward a centralaxis of tray (46), latches (43) flex inward and contact inclined faces(408) of tray (46). With the shape of inclined faces (408), as latches(43) are depressed further when contacting inclined faces (408), tray(46) is driven in a distal direction away from cap (41). This force anddriving motion are sufficient so proximal end (47) separates fromdocking member (not shown) of cap (41), thereby effectively ejectingtray (46) from cap (41).

In an exemplary use, after conducting a biopsy procedure and collectingtissue samples (410) on sample surface (402) of tray (46), a user twistscap (41) to disengage latches (43) from lip (44) of outer cup (42). Withlatches (43) disengaged from lip (44), cap (41) and the attached tray(46) are removed from outer cup (42). A user now visualizes the capturedtissue samples (410). When ready to place the tissue samples (410) intoa container of formalin or other fluid, a user aligns tray (46) with theopening in the container of formalin and then ejects tray (46) bydepressing latches (43) inward toward a central axis of cap (41) andtray (46). The ejection force provided by latches (43) is sufficient toovercome the interference fitting between proximal end (47) of tray (46)and docking member (not shown) of cap (41), thereby depositing tray (46)with tissue samples (410) into the container of formalin or other fluid.At this point, the container of formalin with the samples can be sealedand transported for testing. Further, if desired by a user, another tray(46) may be installed on cap (41) for a subsequent procedure or tocapture additional tissue samples (410).

It should be understood from the foregoing that, in the present example,a user may remove cap (41) from outer cup (42), visualize tissue samples(410), and eject tray (46) from cap (41) without having to repositionthe user's hand on cap (41). For instance, a user may grasp cap (41)along outer sides (412) of latches (43) and can then rotate cap (41) todisengage cap (41) from outer cup (42), followed by depressing latches(43) to eject tray (46). Of course, this one-handed action is notrequired, and in this and other versions repositioning of the user'shand may occur if desired or if necessary. In addition, in the presentexample, the operability of latches (43) is such that when cap (41) isengaged with outer cup (42), latches (43) cannot be sufficientlydepressed to eject tray (46). This is the case because outer cup (42)prevents latches (43) from being able to flex inward and contactinclined faces (408) of tray (46) as described above.

While the above paragraphs describe an exemplary sample holder (40)having a removable tray (46) that is ejected by depressing latches (43),other ways in which to selectively detach tray (46) from cap (41) willbe apparent to those of ordinary skill in the art based on the teachingsherein. By way of example only, cap (41) and tray (46) may be adaptedwith various spring and trigger components where tray (46) may be springloaded to cap (41) and the trigger may be selectively actuated torelease the spring and thereby eject tray (46). Thus, it should beunderstood that interaction between resilient latches (43) and inclinedfaces (408) is just one merely illustrative example.

III. Exemplary Tissue Sample Holder with Threaded Cap

FIGS. 14-16 show exemplary components of a biopsy device that includeouter cup (42), threaded cap (241), and threaded sample container (300).Outer cup (42) of the present example is as described previously,including lip (44) and gaps (45) for selective engagement with latches(243) of cap (241). Engagement of latches (243) is as described abovewith respect to outer cup (42) and latches (43) of cap (41). In additionto latches (243), cap (241) includes internal threads (202). Threads(202) are configured to engage with complementary threads (302) ofsample container (300). While sample containers (300) may come in avariety of sizes, it will be apparent to those of ordinary skill in theart based on the teachings herein that caps (241) may be adapted tofunction with a variety of sample containers (300), including but notlimited to conventional sample containers.

In an exemplary use, after conducting a biopsy procedure and collectingtissue samples, a user twists cap (241) to disengage latches (243) fromlip (44) of outer cup (42). With latches (243) disengaged from lip (44),cap (241) is removed from outer cup (42). A user now visualizes thecaptured tissue samples. In the present example, the tissue samples arecaptured and contained within the space defined by outer cup (42). Asdiscussed above, tissue samples may instead be collected on a tray(e.g., tray (46)), or within a rotatable serial tissue sample capturingstructure as described previously, or by any other suitable means. Basedon the teachings herein, suitable ways to modify the exemplaryconfiguration shown in FIGS. 14-16 to incorporate a tray or other tissuecollection structure will be apparent to those of ordinary skill in theart. It should also be understood that, in some versions (e.g., those inwhich liquid is evacuated from cup (42) at the end of a biopsyprocedure, etc.), the entire biopsy device (10) may be orientedvertically, with tip (22) pointing upward, such that tissue samples areessentially dumped onto the inner surface of cap (241) before cap (241)is removed from cup (42), and such that tissue samples may betransported to sample container (300) on the inner surface of cap (241).

After visualizing the tissue samples, a user then places the tissuesamples into sample container (300). In the present example, a usersimply empties the contents of outer cup (42) into sample container(300), such as by tilting biopsy device (10) with cap (241) removed toessentially dump the tissue samples from cup (42) into container (300).In some versions, a user filters the contents of outer cup (42) suchthat only the tissue samples are emptied into sample container (300). Insome other versions incorporating a tray (46), the tray (46) containingthe tissue samples may be ejected into the sample container (300) asdiscussed above. Based on the teachings herein, other modes oftransferring the tissue samples from the tissue sample holder (40) tosample container (300) will be apparent to those of ordinary skill inthe art. In the present example, sample container (300) is a formalincup used to retain captured biopsy specimens for subsequent analysis ofthe specimens. Of course other types of containers for sample container(300) will be apparent to those of ordinary skill in the art based onthe teachings herein.

With the tissue samples deposited within sample container (300), cap(241) is threadably engaged to the complementary threads of samplecontainer (300). In the present example, latches (243) are configuredsuch that they do not interfere with threadably engaging cap (241) tosample container (300). In some other versions, latches (243) areresilient and act as clamping members on outer surface (304) of samplecontainer (300) in addition, or in the alternative, to the threadedconnection. While the above paragraphs describe an exemplary tissuesample holder (40) having a removable cap (241) that threadably engagesa sample container (300), other ways in which to engage a cap (241) to asample container (300) will be apparent to those of ordinary skill inthe art based on the teachings herein. By way of example only, cap (241)and sample container (300) may be adapted to engage one another using asimilar engagement system as that of cap (241) to outer cup (42). Inother words, sample container (300) may have features configured toengage latches (243) that are similar to lip (44) and gaps (45) of cup(42), etc.

IV. Exemplary Tissue Sample Holder Fluid Management Port

FIGS. 17-18 show an exemplary cap (541) for a tissue sample holder suchas tissue sample holder (40) described above. Cap (541) of this exampleis operably configured to selectively connect with an outer cup (notshown) of a tissue sample holder. In some versions outer cup (not shown)is similar to outer cup (42) as described above. In some such versions,cap (541) may include latches similar to latches (43) described above.However, in the present example, cap (541) threadably connects withouter cup without engaging latches.

Cap (541) comprises port (502) on the distal surface (504) of cap (541),and a seal (506). Seal (506) is operable with port (502) and isgenerally configured to maintain fluid within the outer cup of thetissue sample holder (e.g., when no other device is otherwise connectedwith port (502)). However, port (502) is configured such that a syringe(508) is connectable with port (502) to manage fluid within the outercup. While the present example illustrates and describes syringe (508)as connectable to port (502), other devices suitable to connect to port(502) will be apparent to those of ordinary skill in the art based onthe teachings herein. For instance, an auxiliary or additional vacuummay be coupled to port (502) to provide additional vacuum to pull thetissue into the tissue sample holder, such as in accordance with theteachings of U.S. patent application Ser. No. 12/709,695, entitled“Biopsy Device with Auxiliary Vacuum Source,” filed Feb. 22, 2010, thedisclosure of which is incorporated by reference herein, or otherwise.Alternatively, in a system where the outer cup acts as a collectionreservoir for fluid from the biopsy procedure, when a quantity of fluidhas been captured within the outer cup that would otherwise requireremoving the cap or outer cup to empty the outer cup, a user can insteadconnect syringe (508) (e.g., a 20 cc syringe, etc.) to port (502) andwithdraw excess fluid from within the outer cup. Once the user haswithdrawn the desired amount of fluid, syringe (508) may be disengagedfrom port (502) and the seal (506) retains any left-over fluid orsubsequently captured fluid within the outer cup. Seal (506) alsosubstantially maintains a vacuum within the cup of the tissue sampleholder. It should be understood that syringe (508) may be used to removeliquid from the tissue sample holder one or more times during a biopsyprocedure, even while the needle of the biopsy device is still insertedin a patient (e.g., in a patient's breast, etc.).

In the present example, seal (506) comprises a self-sealing membrane. Asshown in FIG. 18, seal (506) is positioned along the interior wall (510)of cap (541). In use, when syringe (508) is attached to port (502), seal(506) is punctured to allow fluid to be passed between the outer cup andsyringe (508). Once syringe (508) is detached from port (502), theproperties of the membrane seal the puncture thereby restoring theintegrity of seal (506). As another merely illustrative example, seal(506) may be part of a valve that is actuated to open upon coupling ofsyringe (508) with port (502). It should also be understood that port(502) may include a luer lock feature to assist in removably securingsyringe (508) to port (502). Still other suitable structures andconfigurations for a sealing port (502) positioned on a cap (541) of atissue sample holder will be apparent to those of ordinary skill in theart in view of the teachings herein. It should also be understood thatport (502) may include a screen and/or other type of feature configuredto substantially prevent tissue samples or tissue particles fromclogging port (502) as liquid is removed from port (502).

V. Exemplary Tissue Sample Holder with Integrated Marker Delivery Access

FIGS. 19-22 show an exemplary cap (641) and tray (646) of a tissuesample holder (40) incorporating integrated access for marker deliverydevice (1000). In the present example, cap (641) comprises a body (601)with a port (602) on a proximal surface (604) of cap (641). Cap (641)further comprises seal (606), which in the present example is positionedwithin body (601). In some versions, seal (606) comprises an integratedzero closure seal. By way of example only, seal (606) may comprise atwisted diaphragm similar to the seal disclosed in U.S. Pub. No.2008/0146884, entitled “Fully Automated Iris Seal for Hand AssistedLaparoscopic Surgical Procedures,” published Jun. 19, 2008, thedisclosure of which is incorporated by reference herein. As anothermerely illustrative example, seal (606) may comprise an iris sealcomposed of overlapping members similar to the seal disclosed in U.S.Pub. No. 2008/0146882, entitled “Handoscopy Interwoven Layered SealLaparoscopic Disk,” published Jun. 19, 2008, the disclosure of which isincorporated by reference herein. Further still, seal (606) may comprisea proximally-oriented duckbill type seal. Of course, other suitabletypes of seals will be apparent to those of ordinary skill in the art inview of the teachings herein (e.g., a septum seal, etc.). It should alsobe understood that seal (606) may comprise a removable stopper, flap,latch, and/or other feature. Port (602) is configured with a funnelshape or frustoconical in the present example, for easily guiding entryof marker delivery device (1000). Furthermore, in the present example,proximal surface (604) of body (601) has a funnel shape or frustoconicalshape thereby assisting in guiding marker delivery device (1000) to port(602). Any other suitable configurations may be used.

Port (602) leads to a passage (608), which is at least partially definedby tray (646) and runs along the underside length of tray (646). Ahinged ramp (607) is biased downwardly from tray (646) and extendsdistally and downwardly from the top of an arcuate section (616) towarda sample surface (612) of tray (646) such that when tissue samples aretransported proximally through cutter lumen (52), hinged ramp (607)diverts the tissue samples into tray (646). Seal (606) separates port(602) and passage (608) such that seal (606) must be opened orpenetrated by marker delivery device (1000) for marker delivery device(1000) to enter passage (608). Passage (608) ultimately, directly orindirectly through other structures, leads to needle (20) such that aside opening (1004) of deployer tube (1002) of marker delivery device(1000) can be aligned with lateral aperture (23) of needle (20). Forinstance, in the example shown in FIGS. 19-22, when marker deliverydevice (1000) is inserted, marker delivery device (1000) urges ramp(607) upwardly to allow marker delivery device (1000) to continue alongthe axial length of passage (608) into lumen (52) of cutter (50) andtoward needle (20). With this arrangement, a marker (1100) may bedeployed at a biopsy site as described in greater detail above. By wayof example only, passage (608) may align with and lead to cutter lumen(52), such that deployer tube (1002) of marker delivery device (1000)may be fed distally through port (602), along passage (608) (andunderneath ramp (607)), and through cutter lumen (52), until sideopening (1004) is substantially aligned with lateral aperture (23). Insome other versions, sample surface (612) without arcuate section (616)is located below passage (608) such that passage (608) is located abovesample surface (612) and still leads to cutter lumen (52), as will bedescribed below.

Tray (646) of the present example connects with cap (641) and comprisesupright side portions (610), sample surface (612), and openings (614).Upright side portions (610) contain openings (614), which are operablyconfigured for draining fluid from tray (646) as discussed in previousexamples. Of course, in some versions, openings (614) may be entirelyomitted. Sample surface (612) extends between upright side portions(610) and comprises a hinged ramp (607) and an arcuate section (616),which in part defines passage (608)—specifically a section of the upperportion of passage (608), as best seen in FIG. 20. In still otherversions, arcuate section (616) is omitted. For instance, cap (641) andtray (646) may be configured such that port (602) is located at avertical position that is substantially higher than sample surface (612)yet is coaxially aligned with cutter lumen (52), such that a deployertube (1002) has a clear path to cutter lumen (52) via port (602) andsuch that tissue samples gathered on tissue sample surface (612) willnot substantially obstruct passage of deployer tube (1002) to cutterlumen (52) via port (602). Still other suitable configurations will beapparent to those of ordinary skill in the art in view of the teachingsherein.

In use, severed tissue samples are transported to tray (646) asdescribed above. At any point in the sampling procedure, or evenpre-sampling procedure, a marker (1100) can be deployed at a biopsy siteor other site as a reference indicator as discussed above. To place amarker (1100), deployer tube (1002) of marker delivery device (1000) isinserted into port (602). As deployer tube (1002) is advanced distally,deployer tube (1002) contacts seal (606). As deployer tube (1002) isadvanced further distally, deployer tube (1002) enters passage (608).Passage (608) connects with needle (20) such that continued advancementof deployer tube (1002) places deployer tube (1002) within needle (20).Once side opening (1004) of deployer tube (1002) is aligned with lateralaperture (23) of needle (20), marker (1100) is deployed to a desiredsite as described in greater detail above. After marker (1100) has beenplaced, deployer tube (1002) is withdrawn from needle (20) and biopsysample capture begins or continues as the case may be. It should thus beunderstood that a marker (1100) may be deployed without having towithdraw needle (20) from the patient and without having to remove cap(641) or any other component of the tissue sample holder from the biopsydevice (10). While one approach for integrated access for a markerdelivery device (1000) has been discussed above, other approaches and/ormodifications for such integrated access will be apparent to those ofordinary skill in the art based on the teachings herein.

The preceding paragraphs have described various exemplary features for atissue sample holder of a biopsy device. For instance, among others,some of the features include a removable tray (46), a threaded cap (241)configured to threadably engage a sample container (300), a port (502)for withdrawing excess fluid from a tissue sample holder, and integratedaccess for a marker delivery device (1000). Based on the teachingsherein, it will be apparent to those of ordinary skill in the art thatfeatures described herein may be combined or interchanged. For example,a removable tray (46) may be adapted for use with a threaded cap (241)such that once tray (46) is ejected into a sample container (300),remaining cap (241) may be attached to sample container (300) by theabove described system of complementary threads. Similarly, a cap (41)that is operable to eject a tray (46) may also include a port (602)providing access for a marker delivery device (1000). Still othercombinations, interchanges, and variations will be apparent to those ofordinary skill in the art based on the teachings herein.

VI. Additional Exemplary Biopsy Device, Exemplary Recharging Dock, andExemplary Tissue Sample Holders

One exemplary alternative biopsy device (700) is shown in FIG. 23 andcomprises a needle (710), a body (720), a tissue sample holder (800),and a cutter (730). Alternative biopsy device (700) may be configuredsubstantially in accordance with biopsy device (10) describedpreviously. In particular, needle (710) extends distally from the distalportion of body (720), while tissue sample holder (800) extendsproximally from the proximal portion of body (720). A user may graspbody (720), insert needle (710) into a patient's breast, and collect oneor a plurality of tissue samples from within the patient's breast, allwith just using a single hand. In some settings, the user may capture aplurality of tissue samples with just a single insertion of needle (710)into the patient's breast. Such tissue samples may be pneumaticallydeposited in tissue sample holder (800), and later retrieved from tissuesample holder (800) for analysis. While examples described herein oftenrefer to the acquisition of biopsy samples from a patient's breast, itshould be understood that biopsy device (700) may be used in a varietyof other procedures for a variety of other purposes and in a variety ofother parts of a patient's anatomy, including but not limited to apatient's prostate. In the present example, body (720) comprises a probe(722) and a holster (724). Probe (722) and holster (724) are separablecomponents. Needle (710) and tissue sample holder (800) are coupleableto probe (722) while holster (724) houses other internal components,such as those shown in FIG. 2.

Merely exemplary components that may be included in or on biopsy device(700) (beyond those shown in FIG. 2) are shown schematically in FIG. 24.In the example shown, biopsy device (700) includes a control module(750). Control module (750) of the present example includes amicrocontroller configured to control various aspects of biopsy device(700). In one configuration, control module (750) may be configured tostore error data and/or usage data for later analysis. For instance, oneor more sample buttons (760) are coupled to control module (750) andactivate cutter (730) to sever a tissue sample (such as through themotion of cutter (50) depicted in FIGS. 3-6). Such buttons (760) may beincluded on holster (724) and/or on probe (722). An aperture togglebutton (762) is also coupled to control module (750) and toggles cutter(730) between a position where the lateral aperture is open and aposition where the lateral aperture is closed. A sample button LED (764)is coupled to control module (750) and may be configured to indicatewhether sampling of tissue is occurring or not. A probe release button(766) may also be coupled to control module (750) to electronicallytrigger the release of probe (722), though it should be understood thatprobe release button (766) may alternatively be a mechanical release notcoupled to control module (750). Further, one or more LEDs (768) arealso coupled to control module (750) and may be configured to indicatewhether the power source in holster (724) is out of power and/or someother condition. A speaker (770) is also included and is coupled tocontrol module (750) to provide an auditory indication to a user. Suchauditory indications may signal sample taking success, errors, lowpower, no power, biopsy device-readiness, and/or any other auditoryindication. Of course, any or all of these foregoing components may bevaried, substituted, supplemented, or omitted from biopsy device (700).While some various components have been described, still othercomponents will be apparent to one of ordinary skill in the art in viewof the teachings herein.

A. Exemplary Recharging Dock

As noted above, holster (724) is separable from probe (722). In someinstances, such as when holster (724) includes an integral power source,such as power source (60) (e.g., one or more lithium ion batteries,etc.), the power source may need to be recharged between uses or betweena series of uses of biopsy device (700). In such instances, it may bepreferable to include a recharging dock (1200) shown in FIG. 25.Recharging dock (1200) comprises a base (1210), a holster stand (1220),and one or more electrical connectors (1230). Recharging dock (1200) mayfurther include a power cord (not shown) that can be plugged into a walloutlet; or, in some versions, recharging dock (1200) may include abattery within base (1210). Recharging dock (1200) may also furthercomprise one or more communications ports (not shown), such as a USBport, a serial port, an IEEE (or Firewire) port, an Ethernet port, atelephone jack, a Bluetooth transmitter, a wifi device, a WLANconnection, a 3G or 4G connection, and/or any other suitablecommunicative device or port. When inserted into holster stand (1220),holster (724) tilts against holster stand (1220) and is held in place byback wall (1222) and sidewalls (1224), such that holster stand (1220)provides structural support for holster (724). In the present example,electrical connectors (1230) couple to complementary connectors (notshown) on holster (724) when holster (724) is within holster stand(1220). Power and/or data may be transmitted between holster (724) andrecharging dock (1200). In the present example, recharging dock (1200)recharges the power source, such as power source (60), within holster(724) for subsequent procedures. In some versions, recharging dock(1200) may also communicate with control module (750) within holster(724). Such communication may transfer error data and/or usage data to aremote device (such as a user's computer or to a manufacturer's server)for analysis or such communication may be used to reprogram, modify,reset, and/or update control module (750). Still other configurationsand operabilities for recharging dock (1200) will be apparent to one ofordinary skill in the art in view of the teachings herein.

B. Exemplary Alternative Tissue Sample Holder

As shown in FIGS. 26-28, tissue sample holder (800) of the presentexample comprises a cup (810), a tray (830), and a cap (850). In thepresent example, a cutter seal (802) couples a proximal end of cutter(730) to a distal protrusion (811) of cup (810), thereby forming asubstantially fluid seal between cutter (730) and cup (810). Cup (810)includes a vacuum port (812) in fluid communication with a vacuum, suchas vacuum source (70) in holster (724). One or more vacuum passages(813) fluidly couple vacuum port (812) to interior (816) of cup (810).Interior (816) of the present example comprises a substantially openregion of cup (810) configured to releasably receive tray (830) therein.A recess (814) is formed at a distal end of cup (810) and is configuredto receive a distal projection (832) of tray (830) as will be describedbelow. Recess (814) is substantially coaxial to the longitudinal axis ofcutter (730). A flange (818) is disposed about the proximal end of cup(810) and is configured to couple to a proximal cover (822). Inparticular, an annular recess (820) is formed within the proximal faceof flange (818) and is configured to couple to an annular projection(824) of proximal cover (822). By way of example only, annularprojection (824) and annular recess (820) form an interference fit.Alternatively, screws, bolts, clips, snaps, welds, adhesives, or othercoupling items may be used to couple proximal cover (822) to flange(818) Proximal cover (822) further comprises a hollow cylindricalprotrusion (823) to which a lip (852) of cap (850) may couple, asdescribed below.

As seen best in FIG. 28, a pair of ledge members (826) extend distallyfrom proximal cover (822) and into interior (816) of cup (810). Ledgemembers (816) of the present example further include end clips (828)configured to couple to features (not shown) within cup (810) to alsocouple proximal cover (822) to cup (810). Of course, ledge members (816)and/or proximal cover (822) may be omitted or integrally formed with cup(810). In one merely exemplary instance, proximal cover (822) may beremoved when fluid has built up within cup (810). When proximal cover(822) is removed (either by decoupling annular projection (824) fromannular recess (820) or otherwise), the interior of cup (810) may bedumped, disposed of, and/or cleaned. Proximal cover (822) may then bereattached to cup (810) and tissue sample collection may continue.Alternatively, proximal cover (822) may be removed with tray (830) andcap (850) when the tissue samples are removed from biopsy device (700)as will be discussed below.

Tray (830) of the present example comprises a distal projection (832), asample surface (834), a proximal wall (842) and a post (844) extendingproximally from the proximal surface of proximal wall (842). As shownbest in FIG. 27, distal projection (832) is insertable into recess (814)of cup (810) and receives cutter (730). Sample surface (834) extendsproximally from distal projection (832) and, in the present example, ispresented by an arcuate member having a plurality of apertures (836)formed therethrough. Sample surface (834) may further include sidewallsextending vertically from the sides of sample surface (834). Samplesurface (834) is configured to receive tissue samples on top of samplesurface (834) while apertures (836) permit fluid to drop into cup (810).Of course apertures (836) are merely optional and may be omitted. One ormore vacuum apertures (838) are provided on a distal wall of tray (830)such that vacuum from vacuum port (812) may be provided through vacuumpassages (813), through vacuum apertures (838) and into interior (816).As noted in the aforementioned examples, the application of vacuum pullsthe tissue samples through the cutter lumen and into tissue sampleholder (800).

As noted above, tray (830) further comprises proximal wall (842) with apost (844) extending proximally therefrom. Post (844) of the presentexample is a rectangular member configured to be grasped by an innerregion (856) of cap (850), as will be discussed below. It should beunderstood, though, that post (844) may include other geometries,including cylindrical projections, pyramidal projections, pentagonalprisms, and/or other configurations. Post (844) of the present examplefurther includes a flared portion (846) at the proximal end of post(844). Tray (830) also includes a pair of shoulders (840), shown best inFIG. 28. Shoulders (840) are configured to rest atop ledge members (826)of proximal cover (822) such that tray (830) is supported, at least inpart, by proximal cover (822). Shoulders (840), ledge members (826), endclips (828) and the features end clips (828) couple to in cup (810) mayassist in aligning distal projection (832) with the proximal end ofcutter (730) when inserting tray (830) and/or proximal cover (822) intocup (810).

Cap (850) is coupled to proximal cover (822) and includes a distallyextending lip (852), a handle (854), and an inner region (856) formedwithin the distal end of handle (854) and into which flared portion(846) of post (844) is inserted. Cap (850) of the present example isformed of a flexible material, such as a rubber or semi-rigid plastic.Lip (852) is couplable to hollow cylindrical protrusion (823) ofproximal cover (822) and is configured to fluidly seal cap (850) toproximal cover (822). In one merely exemplary configuration, lip (852)frictionally fits to proximal cover (822). Handle (854) is configured tobe gripped by a user such that inner region (856) of handle (854) may becompressed against flared portion (846) to grip post (844).

Once a user has collected the desired tissue samples, the user gripshandle (854) to compress inner region (856) about flared portion (846)of post (844). The user then pulls proximally on handle (854) to removetray (830) from within cup (810). With cap (850) and tray (830), theuser may then maneuver tray (830) above a sample container, such assample container (300), and release the squeezing pressure on handle(854) without necessarily dropping cap (850). With the release ofpressure, inner region (856) resiliently expands to permit flaredportion (846) to slide out of inner region (856). The user maintains agrip on handle (854) to hold onto cap (850) while tray (830) then fallsaway into the sample container. The user may then grip flared portion(846) of another tray (830) to be inserted into cup (810) for use withbiopsy device (700). In one merely exemplary alternative, proximal cover(822) may be detachable from cup (810) such that tray (830), proximalcover (822), and cap (850) are removed together. Removal of proximalcover (822) with tray (830) and cap (850) may permit tray (830) to restupon ledge members (826) when tray (830) is being transported.

Still other configurations for cup (810), tray (830), and cap (850) willbe apparent to one of ordinary skill in the art in view of the teachingsherein.

C. Exemplary Plug Adapter

Once cap (850) and tray (830) have been removed from cup (810), it maybe preferable to a user to mark and/or deliver other medicinal items tothe biopsy cavity formed within the patient's tissue. Accordingly, aplug adapter may be useful to couple to cutter (730) within cup (810).As shown in FIG. 29-30, an exemplary plug adapter (870) may be used withcup (810) described above. Plug adapter (870) includes a body (872), aplug lumen (874) formed longitudinally through body (872), and a seal(876) disposed within the plug lumen (874). Funnels (878, 880) areformed on both the proximal end of plug lumen (874) (funnel (880)) andthe distal end of plug lumen (874) (funnel (878)). Funnel (878) isconfigured to aid the insertion of cutter (730) into plug adapter (870),as shown in FIG. 29, during insertion of plug adapter (870) in cup(810). Funnel (880) is configured to aid the insertion of a markerdeployer, such as marker deployer (1000), into the proximal end of plugadapter (870). Plug adapter (870) further includes an annular shoulder(882) that abuts the proximal end of hollow cylindrical protrusion (823)when plug adapter (870) is inserted therein. In this configuration, plugadapter (870) provides a tubular passageway between the proximal end ofcutter (730) and the exterior of proximal cover (822) such that a markerdeployer may be more easily inserted into cutter (730). Seal (876)fluidly couples to and seals cutter (730) to plug adapter (870) suchthat any fluid within plug lumen (874) does not enter cup (810). Ofcourse, plug adapter (870) may be omitted and the marker deployer may beguided to the proximal end of cutter (730) within cup (810).

In some versions, a medicinal fluid (e.g., pain medications, coagulants,etc.) may be contained within a syringe (not shown) having a distal tube(not shown) that is insertable into plug adapter (870). Plug lumen (874)and/or funnel (880) may be sized such that a seal is formed between pluglumen (874) and/or funnel (880) and the distal tube of the syringe whenthe distal tube is inserted into plug lumen (874) and/or funnel (880).With seal (876) fluidly coupled to cutter (730), the user may inject thefluid contained within the syringe into plug lumen (874) without havingthe fluid enter cup (810). Instead, with cutter (730) in a proximallyretracted position, the fluid travels through cutter (730) and outthrough lateral aperture (23) to the biopsy site. Of course otherarrangements for seal (876) and/or cutter (730) will be apparent to oneof ordinary skill in the art in view of the teachings herein.

In one merely exemplary alternative configuration, funnel (880) may beconfigured as a leur lock or a pierceable membrane such that a syringeor needle with medicinal fluid may be delivered through plug adapter(870) to cutter (730) and, ultimately, out into the biopsy cavity. Lumen(874) may also include one or more features configured to prevent fluidfrom being communicated proximally through lumen (874), while stillallowing a marker applier cannula or other type of device to passdistally through lumen (874). This may reduce the likelihood of bodilyfluids leaking proximally through cutter (730) and thus proximallythrough lumen (874). Still other configurations and uses for plugadapter (870) will be apparent to one of ordinary skill in the art inview of the teachings herein.

D. Another Exemplary Tissue Sample Holder

FIGS. 31-32 depict yet another exemplary tissue sample holder (900)having a cup (910), a tray (940), and a cap (960). In the presentexample, cutter seal (802) couples a proximal end of cutter (730) to adistal protrusion (911) of cup (910), thereby forming a substantiallyfluid seal between cutter (730) and cup (910). Cup (910) includes avacuum port (912) in fluid communication with a vacuum, such as vacuumsource (70). One or more vacuum passages (913) fluidly couple vacuumport (912) to interior (916) of cup (910). Interior (916) of the presentexample comprises a substantially open region of cup (910) configured toreleasably receive tray (940) therein. A recess (914) is formed at adistal end of cup (910) and is configured to receive a distal projection(942) of tray (940) as will be described below. Recess (914) issubstantially coaxial to the longitudinal axis of cutter (730). A flange(918) is disposed about the proximal end of cup (910) and is configuredto couple to a proximal cover (922). In particular, an annular recess(920) is formed within the proximal face of flange (918) and isconfigured to couple to an annular projection (924) of proximal cover(922). By way of example only, annular projection (924) and annularrecess (920) form an interference fit. Alternatively, screws, bolts,clips, snaps, welds, adhesives, or other coupling items may be used tocouple proximal cover (922) to flange (918). Proximal cover (922)further comprises a hollow cylindrical protrusion (923) having a lockpath (938) formed on the interior surface of hollow cylindricalprotrusion (923). Lock path (938) is a helical recess or channel formedwithin the interior surface of hollow cylindrical protrusion (923) andis configured to retain locking nubs (974), as will be described below,similar to a bayonet mounting slot. An outer annular recess (934) isalso formed in hollow cylindrical protrusion (923) and an o-ring (936)is inserted into the outer annular recess (934) to seal hollowcylindrical protrusion (923) to a shoulder portion (976) of a lockingadapter (970), described below.

As seen best in FIG. 32, a pair of ledge members (926) extend distallyfrom proximal cover (922) and into interior (916) of cup (910). Ledgemembers (926) of the present example further include end clips (928)configured to couple to features (not shown) within cup (910) to alsocouple proximal cover (922) to cup (910). Of course, ledge members (926)and/or proximal cover (922) may be omitted or integrally formed with cup(910). In one merely illustrative example, proximal cover (922) may beremoved when fluid has built up within cup (910). When proximal cover(922) is removed (either by decoupling annular projection (924) fromannular recess (920) or otherwise), the interior of cup (910) may bedumped, disposed of, and/or cleaned. Proximal cover (922) may then bereattached to cup (910) and tissue sample collection may continue.Alternatively, proximal cover (922) may be removed with tray (940) andcap (960) when the tissue samples are removed from the biopsy device(700) as will be discussed below.

Tray (940) of the present example comprises a distal projection (942), asample surface (944), a proximal wall (952) and a release member (954)extending proximally from the proximal surface of proximal wall (952).As shown best in FIG. 31, distal projection (942) is insertable intorecess (914) of cup (910) and receives cutter (730). Sample surface(944) extends proximally from distal projection (942) and, in thepresent example, is presented by an arcuate member having a plurality ofapertures (946) formed therethrough. Sample surface (944) may furtherinclude sidewalls extending vertically from the sides of sample surface(944). Sample surface (944) is configured to receive tissue samples ontop of sample surface (944) while apertures (946) permit fluid to dropinto cup (910). Of course apertures (946) are merely optional and may beomitted. One or more vacuum apertures (948) are provided on a distalwall of tray (940) such that vacuum from vacuum port (912) may beprovided through vacuum passages (913), through vacuum apertures (948)and into interior (916). As noted in the aforementioned examples, theapplication of vacuum pulls the tissue samples through the cutter lumenand into tissue sample holder (900). Tray (940) further comprisesproximal wall (952) with a release member (954) extending proximallytherefrom. Release member (954) of the present example includes across-shaped post (956) insertable into an inner region (996) of pushrelease member (990) of cap (960), as will be discussed below. It shouldbe understood, though, that post (956) may include other geometries,including cylindrical projections, pyramidal projections, pentagonalprisms, and/or other configurations. Release member (954) furthercomprises a pair of resilient latches (958), shown in FIG. 32, that areconfigured to selectively couple to a circumferential ledge (979) on theinterior of a locking adapter (970), as will be described in more detailbelow. Resilient latches (958) of the present example are coupled to across member (959) that is configured to bow distally when post (956) ispressed distally by the user. Accordingly, resilient latches (958) bendinwardly and decouple from circumferential ledge (979) when cross member(959) bows distally. Tray (940) also includes a pair of shoulders (950),shown best in FIG. 32. Shoulders (950) are configured to rest atop ledgemembers (926) of proximal cover (922) such that tray (940) is supported,at least in part, by proximal cover (922). Shoulders (950), ledgemembers (926), end clips (928) and the features end clips (928) coupleto in cup (910) may assist in aligning distal projection (942) with theproximal end of cutter (730) when inserting tray (940) and/or proximalcover (922) into cup (910).

Cap (960) of the present example comprises a two-piece assemblycomprising a locking adapter (970) and a push release member (990). Asbest seen in FIG. 32, locking adapter (970) includes a cylindricalprojection (972) having one or more locking nubs (974), a shoulderportion (976), a circumferential ledge (979) formed on the interior oflocking adapter (970), a pair of finger grips (980), and a pair of tabrecesses (982). Cylindrical projection (972) and locking nubs (974) areinsertable into gaps of the lock path or channel formed in proximalcover (922). With nubs (974) inserted a sufficient distance, a userrotates locking adapter (970) such that nubs (974) helically follow thelock path until shoulder portion (976) of locking adapter (970) abutsproximal cover (922). One or more detents may be provided within thelock path to secure nubs (974) at this position, similar to a bayonetmount. Shoulder portion (976) extends proximally from cylindricalprojection (972) and then radially outwardly to form an L-shapedrevolute portion. The bottom of shoulder portion (976) compresses o-ring(936) when nubs (974) are at the end of their respective lock paths,thereby fluidly sealing locking adapter (970) to proximal cover (922).Shoulder portion (976) may further include an indicator (978) toindicate the unlocking/locking rotation necessary to decouple/couplelocking adapter (970) to proximal cover (922). Circumferential ledge(979) is disposed on the interior of the L-shaped revolute portion andis configured to selectively secure tray (940) when resilient latches(958) engage circumferential ledge (979). Flared finger grips (980)extend from the proximal end of shoulder portion (976) and areconfigured to be gripped by one or more fingers of a user. In thepresent example, two recesses (982) are formed within finger grips (980)and are configured to receive tabs (992) of push release member (990),described below.

Push release member (990) comprises a flexible member having a pair oftabs (992), an inner region (996), and a flexible button (994) oppositeinner region (996). Push release member (990) is insertable into lockingadapter (970) with tabs (992) inserting into recesses (982). An adhesivemay be provided to secure tabs (992) in recesses (982). Inner region(996) is configured to receive and frictionally retain post (956)therein. When flexible button (994) is depressed against inner region(996), post (956) is actuated distally relative to push release member(990). As noted previously, when post (956) is actuated distally, crossmember (959) bows distally, thereby bending resilient latches (958)inwardly toward post (956). Accordingly, resilient latches (958) of tray(940) detach from locking adapter (970), and post is expelled out ofinner region (996). Thus, tray (940) is detachable from cap (960).

Once a user has collected the desired tissue samples, the user gripsfinger grips (980) of locking adapter (970) and rotates locking adapter(970) until nubs (974) are aligned with the longitudinal gaps ofproximal cover (922). With nubs (974) and the gaps aligned, the userthen pulls proximally on cap (960) to remove tray (940) from within cup(910). With cap (960) and tray (940), the user may then maneuver tray(940) above a sample container, such as sample container (300), and pushflexible button (994) distally to disengage resilient latches (958) andto dislodge post (956) from within inner region (996). Post (956) thenslides out of inner region (996) and tray (940) then falls away into thesample container. The user may continue to grip finger grips (980) toalign and insert post (956) of another tray (940) to be inserted intocup (910) for use with biopsy device (700).

Still other configurations for cup (910), tray (940), and cap (960) willbe apparent to one of ordinary skill in the art in view of the teachingsherein.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. A device for use in a biopsy procedure, wherein thedevice comprises: a. a body portion; b. a needle, wherein the needleextends distally from the body portion, wherein the needle comprises: i.an outer cannula defining an inner lumen, ii. a tip, and iii. a lateralaperture configured to receive tissue, wherein the lateral aperture isproximal to the tip; c. a cutter, wherein the cutter is operablyconfigured to translate relative to the needle to sever a tissuespecimen from tissue received within the lateral aperture; and d. atissue sample holder, wherein the tissue sample holder is configured toreceive tissue specimens severed by the cutter, wherein the tissuesample holder comprises: i. an outer cup, wherein the outer cup definesan interior space, ii. a cap, wherein the cap is selectively coupledwith the outer cup, and iii. a tray, wherein the tray is configured tohold the severed tissue specimens, wherein the tray is selectivelycoupled with the cap.
 2. The device of claim 1, wherein the traycomprises a proximal end, and wherein the cap comprises a receivingmember, wherein configurations of the proximal end of the tray and thereceiving member complement one another to provide an interferencefitting between the proximal end of the tray and the receiving member.3. The device of claim 1, wherein the cap comprises a handle and aninner recess extending proximally into the handle, wherein the traycomprises a post, and wherein the post is insertable into the innerrecess of the cap.
 4. The device of claim 3, wherein the cross-sectionalarea of the inner recess is greater than the cross-sectional area of thepost.
 5. The device of claim 4, wherein the handle comprises adeformable material.
 6. The device of claim 1, wherein the cap comprisesa push release button, wherein the tray comprises a post, and whereinthe post is insertable into an inner region defined by one or moredistal extensions from the push release button.
 7. The device of claim6, wherein the push release button comprises a flexible button, whereinthe post is selectively releasable from the push release button bydepressing the flexible button.
 8. The device of claim 6, furthercomprising a locking adapter coupled to the push release button andselectively coupleable to the outer cup.
 9. The device of claim 1,wherein the tray comprises a sample surface, a proximal end, and a pairof side portions, wherein the sample surface extends distally from theproximal end between the pair of side portions, wherein the samplesurface includes a plurality of openings configured to drain fluid fromthe tray.
 10. The device of claim 9, wherein the tray comprises atransparent plastic material.
 11. The device of claim 1, wherein the capis selectively coupled with the outer cup by one or more latches, andwherein the cap comprises a threaded portion configured to engage acomplementary threaded portion of a separate sample container.
 12. Thedevice of claim 1, wherein the cap includes a port providing selectivefluid communication through the cap.
 13. A device for use in a biopsyprocedure, wherein the device comprises: a. a body portion; b. a needle,wherein the needle extends distally from the body portion, wherein theneedle comprises: i. an outer cannula defining an inner lumen, ii. atip, and iii. a lateral aperture configured to receive tissue, whereinthe lateral aperture is proximal to the tip; c. a cutter, wherein thecutter is operably configured to translate relative to the needle tosever a tissue specimen from tissue received within the lateralaperture; and d. a tissue sample holder, wherein the tissue sampleholder is configured to receive tissue specimens severed by the cutter,wherein the tissue sample holder comprises: i. an outer cup, wherein theouter cup defines an interior space, ii. a tissue tray removablyreceived in the interior space of the cup, and iii. a deformable capremovably secured relative to the outer cup, wherein the cap is operableto selectively engage the tissue tray.
 14. The device of claim 13,wherein the cap is deformable to selectively engage the tissue tray. 15.The device of claim 13, wherein the cap is deformable to selectivelyengage the outer cup.
 16. The device of claim 13, wherein the tissuetray and cap are removable together from the outer cup as an assembly.17. A method of operating a biopsy device, wherein the biopsy deviceincludes a cannula, a cutter, and a tissue sample holder, wherein thecannula includes a transverse tissue receiving aperture, wherein thecutter is configured to sever samples from tissue received through thetransverse tissue receiving aperture, wherein the tissue sample holderis configured to receive one or more tissue samples severed by thecutter, wherein the tissue sample holder comprises a chamber, a traydisposed in the chamber, and a cap releasably engageable with the tray,the method comprising: (a) actuating the cutter to sever at least onetissue sample; (b) communicating the at least one tissue sample to thetray of the tissue sample holder; (c) removing the cap, the tray, andthe at least one tissue sample together from the chamber; and (d)releasing the tray from the cap.
 18. The method of claim 17, wherein thecap includes a handle defining an inner recess, wherein the trayincludes a protrusion disposed in the inner recess, wherein the act ofremoving the cap, the tray, and the at least one tissue sample comprisespinching the handle to deform the inner recess, thereby grasping theprotrusion, wherein the act of releasing the tray from the cap comprisesrelieving pressure on the handle to un-deform the inner recess, therebyreleasing the protrusion.
 19. The method of claim 17, wherein the act ofreleasing the tray from the cap is performed with a single hand, withoutgrasping the tray with another hand.
 20. The method of claim 17, furthercomprising: (a) inserting a plug into the chamber after the cap, thetray, and the at least one tissue sample are removed from the chamber,wherein the plug defines a lumen aligned with the cutter; and (b)inserting an instrument through the lumen of the plug and into thecutter.